Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old;

Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;

Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);

Signed written informed consent to personal data treatment for research purposes

Disqualifiers

Age <18 years old;

Refusal to sign the written informed consent to personal data treatment for research purposes.

Trial population

Oncologic patients (with multiple myeloma, lymphoma, melanoma and metastatic cancer, such as prostate, breast and gynecologic cancers. Another application of WB-MRI is the imaging of patients with certain cancer predisposition syndromes

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Enhanced Diffusion Software

    Device

    Application of specific sequences with the use of Enhanced Diffusion Software during Patient MRI

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Radiologists' satisfaction of the quality of images

Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items

Time frame
18 months

Secondary outcomes

1

Diagnostic accuracy of the de-noised WB-MRI in detecting lesions

Comparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,

Time frame
18 months
2

Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.

Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.

Time frame
18 months

Other outcomes

Sponsors and contacts

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